Results of a phase III study of Celltrion’s infliximab biosimilar (Remsima; CT-P13) ‘indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease is comparable to those treated with reference infliximab’.
The phase III randomized controlled trial included 220 patients with moderate-to-severe CD and examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients. According to the 6-week and 30-week data, similar clinical remission, CDAI-70 (a fall of 70 or more points) and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.
The results were presented at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), which was held on 15‒18 February 2017 in Barcelona, Spain.
Celltrion also presented data from two observational studies. The first study evaluated the efficacy and safety of CT-P13 in 74 paediatric patients with CD (naïve patients: 26, switch patients: 25) or ulcerative colitis (UC) (naïve patients: 16, switch patients: 7). The data show that CT-P13 is effective in both treatment-naïve and switch paediatric patients over 30 weeks and is well tolerated.
The second study examined 204 CD patients (fistulising CD: 24, CD patients: 180) in South Korea from July 2012‒2016. CT-P13 was found to be clinically consistent to reference infliximab and well tolerated up to six months in patients with moderate-to-severe CD and those with fistulising CD.
Celltrion’s infliximab biosimilar (Remsima) was approved by the European Medicines Agency (EMA) in September 2013 [1], follow by a marketing application submission for its rituximab biosimilar CT‑P10 to EMA in November 2015 [2]. The company also received approval for its infliximab biosimilar (CT-P13) in the US in April 2016, claiming it to be the first monoclonal antibody biosimilar approved in the US [3]. In October 2016, the company submitted a marketing application for its trastuzumab biosimilar CT‑P6 to EMA [4]. In December 2016, Celltrion received approval for its rituximab biosimilar Truxima (CT P10) from EMA [5].
Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.
Related article
Positive phase III results for Celltrion’s rituximab biosimilar
References
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2. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits rituximab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-rituximab-biosimilar-application-to-EMA
3. GaBI Online - Generics and Biosimilars Initiative. FDA approves infliximab biosimilar Inflectra [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-infliximab-biosimilar-Inflectra
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion submits trastuzumab biosimilar application to EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-submits-trastuzumab-biosimilar-application-to-EMA
5. GaBI Online - Generics and Biosimilars Initiative. EMA approval for rituximab biosimilar Truxima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 10]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-rituximab-biosimilar-Truxima
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